Model Number W1DR01 |
Device Problem
Appropriate Term/Code Not Available (3191)
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Patient Problems
Wound Dehiscence (1154); Hemorrhage/Bleeding (1888)
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Event Date 03/13/2024 |
Event Type
Injury
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Event Description
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It was reported that the patient said " the incision ripped open and i was bleeding.I went back and they stitched in up inside.The area around it is red and sticks out".The implantable pulse generator (ipg) remains in use. no further patient complications have been reported as a result of this event.
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Manufacturer Narrative
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Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
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Manufacturer Narrative
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Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
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Event Description
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It was reported by the patient that the incision had some black under it and appeared to be opening up.
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Search Alerts/Recalls
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